edoxaban是每日口服一次的抗凝血剂，通过抑制凝血因子Xa发挥作用。目前，第一三共正在调查edoxaban用于房颤患者预防中风。FDA审查员认为，60mg剂量edoxaban在轻度肾功能受损的患者群体中疗效明显优于广泛使用的抗凝血剂老药华法林（warfarin），但在肾功能正常的患者群体中的药物副作用也非常明显。总的研究数据支持了edoxaban的有效性，但基线肾功能（baseline renal function）疗效预后可能潜在影响edoxaban的批准或药物标签。
FDA将在2天后召开独立专家会议，就是否应该批准edoxaban听取专家们的意见。FDA在做出最终审查决定时，尽管没有义务遵循专家小组的建议，但通常都会采纳。FDA内部审查员同时指出，尽管edoxaban与华法林一样有效，但市面上已有另外2种药物比华法林更有效。
根据第一三共一年前公布的III期临床数据，edoxaban在预防中风及特定血液栓塞方面比华法林更安全，同时大出血事件更少，而大出血是血液抗凝剂类药物的最大风险。华法林上市已超过半个世纪，能够有效预防中风，但该药的使用必须监测血药浓度、剂量调整及饮食限制。
如果获批，edoxaban将以品牌名Savaysa上市，同时将与市面上的其他同类产品展开竞争，包括拜耳和强生的拜瑞妥（Xarelto，rivaroxban）、百时美和辉瑞的Eliquis（apixaban，阿哌沙班）以及勃林格殷格翰的Pradaxa（dabigatran，达比加群）。edoxaban和Xarelto每日口服一次，Eliquis和Pradaxa每日口服2次。
此外，监管部门也正在审查edoxaban治疗静脉血栓栓塞（VTE）的上市申请。edoxaban于2011年4月在日本上市，品牌名为Lixiana，用于预防骨科大手术后静脉血栓栓塞（VTE）。在其他地理区域，包括欧洲和美国，edoxaban正处于III期临床开发。
关于edoxaban：
edoxaban是一种实验性、口服、每日一次的抗凝血剂，能够可逆性抑制凝血因子Xa。全球性edoxaban临床项目包括2个III期研究：Hokusai-VTE和ENGAGE AF-TIMI48。前者在深静脉血栓（DVT）和/或肺栓塞（PE）患者中开展，评价edoxaban对症状性静脉血栓栓塞（VTE）复发的治疗和预防。后者在非瓣膜性心房颤动（AF）患者中开展，评价edoxaban对中风和全身性栓塞事件（SEE）的预防。
英文原文：updat 1-FDA staff recommends limited use of Daiichi's blood thinner
Oct 28 (Reuters) - U.S. Food and Drug Administration staff reviewers recommended approval of a 60 mg dose of Daiichi Sankyo Co's blood thinner for some atrial fibrillation patients, but suggested limiting its use to those with abnormal kidney function.
The drug, edoxaban, is a once-daily anticoagulant that inhibits Factor Xa, a protein that plays a central role in blood-clotting.
Edoxaban is being considered for use in some patients with atrial fibrillation, characterized by a rapid and irregular heartbeat that can cause strokes.
While the 60 mg dose of the drug was markedly superior to widely-used anticoagulant warfarin in mildly renally impaired patients, it was almost significantly worse in patients with normal renal function, the reviewers said.
"Although the ... overall findings support effectiveness, efficacy outcomes by baseline renal function have potential implications for approval or labeling."
The report comes two days ahead of a meeting of independent experts to discuss the drug and recommend whether it should be approved.
While the FDA is not obligated to follow the recommendations of its advisory panels, it typically does so.
Although edoxaban is as effective as warfarin, two other currently approved drugs are more effective than warfarin, agency staff noted. (1.usa.gov/1wHOZW8)
"It's obvious to question whether edoxaban could be inferior to other approved therapies and whether this constitutes a reason not to approve."
Data from a late-stage trial of edoxaban released a year ago also showed it was safer than warfarin in preventing strokes and certain blood clots, and associated with less major bleeding, the biggest risk with blood thinners. (reut.rs/1FSHM8z)
Warfarin, which has been on the market for over half a century, is effective in preventing strokes but its use necessitates blood level monitoring, dose adjustments and dietary restrictions.
If approved, edoxaban, will compete with other drugs in its class, including Xarelto, sold by Bayer AG and Johnson & Johnson ; and Eliquis, sold by Bristol-Myers Squibb Co and Pfizer Inc.
It will also compete with Pradaxa, made by privately held Boehringer Ingelheim.
While Edoxaban and Xarelto are once-daily pills, Eliquis and Pradaxa are taken twice a day.
Savaysa, which is the proposed brand name for edoxaban in the United States, is also undergoing regulatory review for the treatment of venous thromboembolism (VTE).
Launched as Lixiana since 2011 in Japan, it is used in the prevention of VTE after major orthopaedic surgery. (Reporting by Natalie Grover in Bangalore and Toni Clarke in Washington; Editing by Simon Jennings)
|手机版|药群论坛
( 蜀ICP备15007902号 )
收藏
支持
反对